An interventional study of Intervention Group and Control in Pain and Anxiety, sponsored by Ataturk University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Ataturk University · Not applicable, Interventional, and Supportive care
The aim of this study is to evaluate the effect of Shotblocker, administered during lumbar puncture, on patients' pain levels, anxiety levels, and cortisol levels (a physiological stress indicator). This randomized controlled trial aims to scientifically demonstrate the effectiveness of Shotblocker use in reducing pain and anxiety during and after the procedure, and its effect on the stress response, compared to standard practice.
Lumbar puncture is an invasive procedure that can cause pain, anxiety, and a physiological stress response in patients during the procedure. This stress response is associated with an increase in cortisol levels and can negatively affect patient comfort.
While pharmacological methods are used to control pain and anxiety associated with invasive procedures, these methods have disadvantages such as sedation, risk of side effects, prolonged post-procedure recovery time, and additional costs. Therefore, research into safe, easily applicable, and side-effect-free non-pharmacological methods is gaining importance.
Shotblockers are a safe and non-invasive method aimed at reducing pain perception through mechanical pressure. Although their effect on injection pain has been demonstrated in the literature, randomized controlled trials examining their combined effect on pain, anxiety, and cortisol levels during lumbar puncture are limited. Furthermore, research using cortisol levels as a physiological stress indicator is insufficient. This randomized controlled trial aims to evaluate the effect of shotblocker use during lumbar puncture on patients' perceived pain and anxiety levels, as well as on cortisol levels, a biochemical stress indicator. The study aims to reduce selection bias between groups and increase the scientific validity of the results by using a randomization method. The combined use of subjective measurements (pain and anxiety scales) and objective measurements (cortisol levels) will strengthen the reliability of the data obtained. It is anticipated that this research will contribute to evidence-based practices aimed at improving patient comfort in lumbar puncture procedures, support the integration of non-pharmacological interventions into clinical practice, and help improve the quality of patient care.
2,450 studies on the registry are indexed under Pain; 945 are open to participants now.
This study's planned enrollment of 68 is close to the median of 70 across 2,101 interventional studies indexed under Pain.
Browse Pain studies →Ataturk University is the lead sponsor of 454 studies on the registry; 123 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients in the intervention group were informed about the lumbar puncture procedure, and the ShotBlocker device was applied during the procedure.
Other: Intervention Group
Patients in the control group received standard care and treatment during the lumbar puncture procedure.
Other: Control
Patients will receive routine monitoring, pharmacological treatment, and nursing care. Under aseptic precautions, lumbar puncture will be performed in all groups using a 25-gauge Quincke spinal needle at the L3-L4 or L4-L5 intervertebral space, with patients in the lateral position. In the ShotBlocker group, after skin preparation and draping, the sterilized ShotBlocker will be placed at the puncture site and firmly pressed for 10 seconds with the non-dominant hand. The spinal needle will then pass through its slit. Methylprednisolone and bupivacaine hydrochloride will be administered into the epidural space. Saliva samples will be collected before and after the procedure for cortisol measurement. Pain and anxiety will be assessed before and 10 minutes after lumbar puncture. The procedure will be performed by the same physician in all groups.
In our research, the "Personal Information Form" will be applied to the control group patients without any intervention other than the clinical protocol. "Visual Analog Scale" and "State Anxiety Scale" will be applied to the patients 10 minutes before the lumbar puncture procedure. Saliva samples will be collected from patients before and after the lumbar puncture, and the collected samples will be stored under appropriate laboratory conditions for measurement of cortisol level. 10 minutes after the procedure is completed, the pain and anxiety levels experienced will be re-evaluated with scales.
Personal Information Form
This form, created by the researcher, contains a total of 8 questions covering the patients' age, gender, education level, marital status, height/weight, body mass index, and questions about their illness.
Time frame: At baseline, before the intervention
Visual Analog Scale
This scale ranges from 0, indicating "No pain," to 10, indicating "Unbearable pain." The patient is asked to rate the intensity of pain on a scale from 0 to 10. The selected value represents the patient's pain score.
Time frame: 10 minutes before and 10 minutes after the lumbar puncture procedure
State Anxiety Scale
The State-Trait Anxiety Inventory (STAI) assesses anxiety in individuals aged 14 years and older. The 20-item State Anxiety Inventory used in this study is a 4-point Likert scale: "not at all" (1), "somewhat" (2), "moderately so" (3), and "very much so" (4). Items 1, 2, 5, 8, 10, 11, 15, 16, 19, and 20 are reverse-scored (1=4, 2=3, 3=2, 4=1). Scores are summed according to the scoring procedure, with a constant value of 50 added to obtain the final anxiety score. Total scores range from 20 to 80, with higher scores indicating greater anxiety.
Time frame: 10 minutes before and 10 minutes after the lumbar puncture procedure
Salivary Cortisol Level
Salivary cortisol levels will be measured using commercially available kits with the ELISA method.
Time frame: 10 minutes before and 30 minutes after the lumbar puncture procedure
No study locations are listed for this record.
Plan to share: No — Individual participant data will not be shared with researchers outside the study team due to participant confidentiality and data privacy considerations.
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Oct 2026, 0 months later.
Of 1,253 non-industry interventional studies with no phase under Pain, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 29. This study's planned 0 months is below that.
Counting every sponsor, half of 1,276 studies reached it within 11 months; a quarter within 5 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.